Clinicians who suspect their patients may have immune thrombocytopenia (ITP) should look for platelet autoantibodies both in the bloodstream and the bone marrow, new research suggests. "Diagnosing ITP ...
Hutchmed is gearing up to submit sovleplenib for approval in the company’s native China after the Syk inhibitor scored a phase 3 win. The placebo-controlled trial enrolled 188 adults in China with ...
A Prescription Drug User Fee Act target date of July 24, 2025 has been set for the sNDA application. The Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) ...
The European Medicines Agency (EMA) has recommended granting marketing authorization for rilzabrutinib (Wayrilz, Sanofi) to treat immune thrombocytopenia (ITP) in adults who are refractory to other ...
An investigational anti-CD38 monoclonal antibody (CM313) rapidly increased platelets in immune thrombocytopenia (ITP) patients to levels sufficient for preventing bleeding, a small single-arm Chinese ...
(RTTNews) - Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (SWTUY.PK), Thursday said that the U.S. Food and Drug Administration or FDA has accepted its supplemental ...
Novartis AG (NYSE:NVS) released topline results on Tuesday from the VAYHIT2 Phase 3 trial evaluating ianalumab plus eltrombopag in patients with primary immune thrombocytopenia (ITP) previously ...
Novartis said its ianalumab drug combined with eltrombopag met the primary endpoint in a late-stage trial, demonstrating a significant improvement in time to treatment failure for patients with ...
The FDA also approved Doptelet Sprinkle oral granules for use in children aged 1 to less than 6 years. The Food and Drug Administration (FDA) has approved Doptelet ® (avatrombopag) for the treatment ...
Please provide your email address to receive an email when new articles are posted on . Eltrombopag increased durable platelet response for children with newly diagnosed immune thrombocytopenia.
SAN DIEGO — Phase 3 data support rilzabrutinib as a potential first-in-class oral Bruton tyrosine kinase (BTK) inhibitor for patients with previously treated immune thrombocytopenia (ITP). In the LUNA ...
Please provide your email address to receive an email when new articles are posted on . Most treated patients had two consecutive platelet counts of at least 50 × 10 9 /L within 8 weeks of the first ...